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Brivanib+ Cetuximab

Phase 1

Colorectal Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 25, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Brivanib+ Cetuximab · 1 trial · 1 indication

Phase 1 1
NCT00207051BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal MalignanciesColorectal Cancer
COMPLETED62 Analytics
PHASE1COMPLETED
BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety assessment
throughout the study
dose limiting toxicity (DLT)
assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximu tolerated dose is identified

Secondary Endpoints

Efficacy based on duration of response and time to progression based on assessment
Measured every 8 weeks throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Brivanib + CetuximabDRUGTablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Diagnosis of advanced or metastatic (tumor has spread) gastrointestinal malignancy * Feeling well other than cancer diagnosis (ie lab work, no infection, etc) * Available tumor tissue sample from prior surgery * Measurable disease on scans * 4-6 weeks since prior therapy and r...

Countries:United StatesCanadaNetherlands
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Frequently asked questions about Brivanib+ Cetuximab

What is Brivanib used for?

Brivanib is an investigational small molecule being studied for the treatment of solid tumors, hepatocellular carcinoma (HCC), liver cancer, and gastrointestinal cancers. It has been evaluated in clinical trials for these oncology indications, including advanced or metastatic solid tumors and hepatocellular carcinoma.

Who makes Brivanib?

Brivanib is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has sponsored clinical trials of Brivanib in patients with various cancers, including hepatocellular carcinoma and solid tumors.

What phase is Brivanib in?

Brivanib is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains in clinical development. All three completed trials were uncontrolled, meaning they did not include a comparison group.

What clinical trials has Brivanib been in?

Brivanib has been studied in three completed clinical trials. NCT00355238 was a Phase 2 study in hepatocellular carcinoma with 137 patients. NCT00390936 was a Phase 1 study in advanced solid tumors with 13 patients. NCT00437424 was a Phase 1 study in hepatocellular carcinoma with liver dysfunction, enrolling 24 patients.

Is Brivanib the same as BMS-582664?

Yes, Brivanib is also known as BMS-582664. Clinical trial records refer to the drug by both names, such as in the Phase 2 study of BMS-582664 in hepatocellular carcinoma and the Phase 1 study of Brivanib in liver cancer.